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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 9MM/130 DEG TI CANN TFNA 235MM/RIGHT - STERILE ROD, FIXATION, INTRAMEDULLARY

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC 9MM/130 DEG TI CANN TFNA 235MM/RIGHT - STERILE ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Model Number 04.037.944S
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Injury (2348); No Code Available (3191)
Event Date 11/01/2018
Event Type  Injury  
Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation. Device not implanted or explanted. (b)(4). Without a lot number the device history records review could not be completed. Product was not returned. Based on the information available, it has been determined that no corrective and/or preventative action is proposed. This complaint will be accounted for and monitored via post market surveillance activities. If additional information is made available, the investigation will be updated as applicable. Device was used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
It was reported that on (b)(6) 2018, during hip surgery, the sales consultant (sc) passed off the wrong degree of the trochanteric fixation nail advanced (tfna) to the field. The surgeon asked for a 125 but a 130 nail was passed by him. The blade would not enter into the head of the patient and began to run through possible scenarios. Sc checked the box in the trash and it was a 130 nail. The nail was removed, and the correct nail was passed to the field. There was a surgical delay of ten (10) minutes and then proceeded. This report is for one (1) 9mm/130 deg ti cann tfna 235mm/right-sterile. This is report 1 of 1 for complaint (b)(4).
 
Manufacturer Narrative
Device was used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
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Brand Name9MM/130 DEG TI CANN TFNA 235MM/RIGHT - STERILE
Type of DeviceROD, FIXATION, INTRAMEDULLARY
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
Manufacturer (Section G)
MONUMENT
1101 synthes avenue
monument CO 80132
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key8121851
MDR Text Key129024521
Report Number2939274-2018-55218
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K160167
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/01/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/01/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number04.037.944S
Device Catalogue Number04.037.944S
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/14/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 12/01/2018 Patient Sequence Number: 1
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